A traditional chinese medicine composition for improving obesity

Abstract

This invention discloses a traditional Chinese medicine composition for improving obesity, belonging to the field of traditional Chinese medicine technology. Based on the core microscopic pathogenesis of obesity, this invention believes that the disease is caused by hepatic capillary constriction and hepatic microcirculation stagnation, leading to impaired hepatic glycogen synthesis, which in turn causes sugar accumulation, internal generation of phlegm and dampness, and ultimately, dysfunction of glucose and lipid metabolism. The formula is composed of five medicinal and edible herbs: citron, jujube seed, chicken gizzard lining, peppermint, and platycodon. This composition can dilate constricted and narrowed hepatic capillaries, repair hepatic microcirculation perfusion levels, and restore the physiological function of hepatocyte glycogen synthesis; simultaneously, it has the effects of soothing the liver and unblocking the meridians, strengthening the spleen and resolving turbidity, and regulating the three jiaos (upper, middle, and lower burners), which can regulate the function of the hypothalamic feeding center, fundamentally resolve the problem of internal phlegm and dampness, correct glucose and lipid metabolism disorders, and achieve a conditioning effect that addresses both the symptoms and the root cause. This product can be applied to the improvement and conditioning of simple obesity, abdominal obesity, and metabolic obesity. The medicinal materials used in this invention are concise and refined, with mild and gentle medicinal properties, no obvious toxic side effects, and are suitable for long-term daily conditioning. They can be processed into various dosage forms such as herbal tea, powder, granules, pills, ointments, and oral liquids, and have broad prospects for industrial application.

Description

Technical Field

[0002] This invention relates to the field of traditional Chinese medicine compound formulation technology, food and medicine homology health conditioning product technology, and human metabolic sub-health conditioning, specifically to a traditional Chinese medicine composition for improving obesity based on liver microcirculation regulation, improving liver glycogen synthesis disorder, and intervening in phlegm-dampness and glucose-lipid metabolism disorder. Background Technology

[0004] Obesity is a prevalent chronic metabolic sub-health problem, often accompanied by complications such as abnormal glucose and lipid metabolism, decreased insulin sensitivity, fatty liver, and metabolic syndrome. Prolonged obesity can seriously affect physical and mental health and metabolic homeostasis. Traditional Chinese medicine (TCM) understanding of the pathogenesis of obesity is largely limited to a macroscopic diagnostic system, categorizing it under conditions such as "spleen deficiency with dampness accumulation, phlegm-dampness retention, liver qi stagnation, stomach heat accumulation, and spleen and kidney deficiency." Routine clinical interventions mainly include oral herbal medicine, acupuncture, acupoint therapy, and dietary intervention. Existing TCM formulas for weight loss are mainly divided into two major systems: those for strengthening the spleen and removing dampness, and those for purging heat and promoting bowel movements.

[0005] Conventional spleen-strengthening and dampness-removing formulas often use commonly used medicinal materials such as Poria cocos, Coix seed, Atractylodes macrocephala, Atractylodes lancea, lotus leaf, hawthorn, Alisma plantago-aquatica, and winter melon peel. Modern pharmacological studies have confirmed that these medicinal materials can, to a certain extent, strengthen the spleen, promote diuresis, remove dampness, lower lipids, and assist in regulating the body's glucose and lipid metabolism. Among them, chicken gizzard membrane can soothe the tension of hepatic sinusoidal capillaries, reduce intrahepatic blood flow resistance, improve hepatic microcirculation perfusion, downregulate the abnormal expression of hepatic aquaporins, reduce abnormal water and sodium retention in the liver, and activate the body's AMPK metabolic pathway to help correct the disordered state of hepatic glucose metabolism; Poria cocos polysaccharides can promote the release of hepatic nitric oxide, soothe spasmodic hepatic capillaries, reduce the expression of vasoconstrictors, improve hepatic microcirculation stagnation, reduce abnormal fluid accumulation in the body, and help improve insulin sensitivity and inhibit abnormal hepatic gluconeogenesis; Coix seed, Atractylodes macrocephala, and winter melon peel... Atractylodes macrocephala and Atractylodes lancea can repair the physiological function of hepatic sinusoidal endothelial cells, reduce low-grade inflammation and tension spasm in hepatic microvessels, regulate the rhythm of water metabolism in the Triple Burner, and help improve systemic glucose and lipid metabolism disorders. Lotus leaf contains lotus leaf alkaloids and flavonoid active ingredients, which can upregulate the expression of eNOS in hepatic vascular endothelium, promote NO release, soothe spasmodic and contracted hepatic capillaries and sinusoidal microvessels, and help correct abnormal hepatic glucose metabolism. The active ingredients in winter melon can soothe the state of hepatic sinusoidal microcirculation, moderately inhibit the activity of enzymes related to hepatic fat synthesis, and intervene in the abnormal conversion process of glucose and lipids.

[0006] Most weight loss formulas currently on the market heavily rely on heat-clearing and laxative herbs such as rhubarb, senna leaves, cassia seeds, mirabilite, and aloe vera. Modern pharmacological research has confirmed that these herbs mainly stimulate the intestinal mucosa and accelerate intestinal excretion through their anthraquinone and sennoside components, achieving short-term weight loss through drainage. They cannot fundamentally relieve the tension in the liver capillaries, repair liver microcirculation damage, or correct metabolic disorders. They can only achieve short-term symptomatic relief, and long-term use can easily induce pathological stress damage to multiple organs, resulting in poor overall safety.

[0007] Modern pharmacological and animal experimental studies have shown that long-term use of purgative drugs for weight loss can easily induce a multi-level chain of stress damage to the body, including damage to liver microcirculation, abnormal liver glycogen synthesis and metabolism, abnormal accumulation of sugar in the body, disorder of the hypothalamic metabolic center, and increased cardiovascular load.

[0008] The hepatic sinusoidal capillaries are the core microcirculatory structures for material exchange and energy metabolism in the liver. Under normal physiological conditions, the inner diameter of the hepatic sinusoidal capillaries in humans and experimental rats is 7–12 μm, with an average of about 10 μm. The capillaries are wide and perfused, ensuring normal blood oxygen supply, glucose uptake, glycogen synthesis, and lipid metabolism in hepatocytes. Authoritative anatomical and microcirculatory experiments have confirmed that under conditions of obesity, hyperlipidemia, and liver stagnation stress, the hepatic sinusoidal endothelial function is abnormal, and vasoconstrictor factors are highly expressed. The hepatic sinusoids can undergo persistent pathological spasm and contraction, and the capillary diameter can pathologically shrink to 4–5 μm, which is significantly lower than the normal physiological range of 7–12 μm. This directly causes insufficient hepatic microcirculatory perfusion and increased blood flow resistance, thereby blocking the blood oxygen supply, glucose transport, and material exchange processes of hepatocytes and disrupting the normal metabolic basis of the liver [3,8,12,15].

[0009] The specific pathological damage process is as follows:

[0010] 1. It induces spasm and contraction of hepatic capillaries, thus hindering the exchange of substances involved in hepatic glucose metabolism.

[0011] The anthraquinones and sennosides contained in rhubarb and senna leaves can abnormally increase vasoconstrictor factors such as angiotensin II and endothelin-1 in the liver, inducing persistent tension and spasm of hepatic microvessels. Long-term intervention with laxatives will cause abnormally increased amplitude of hepatic capillary contraction, significant narrowing of the physiological diameter of hepatic sinusoids, decreased effective perfusion of hepatic microcirculation, and increased intrahepatic blood flow resistance, directly blocking the processes of blood oxygen supply, glucose transport, and substance exchange in hepatocytes, thus disrupting the normal metabolic basis of the liver.

[0012] 2. Interferes with liver glycogen synthesis and metabolism, leading to blood glucose retention and abnormal accumulation of glucose.

[0013] Persistent spasm and stagnation of hepatic capillaries directly damage the normal physiological metabolic function of hepatocytes and interfere with the normal activity of key enzymes in glycogen synthesis. Existing animal model studies have confirmed that under conditions of impaired hepatic sinusoidal microcirculation, the activity of hepatocyte glycogen synthase is reduced, while the activity of glycogen phosphorylase is relatively increased, leading to a weakening of the overall glycogen synthesis and storage function of the liver. Abnormal liver glycogen reserve capacity prevents the timely conversion and storage of excess glucose in the blood, easily causing abnormal retention and accumulation of glucose in the bloodstream and interstitial spaces, disrupting systemic glucose homeostasis.

[0014] 3. Sugar accumulation induces osmotic imbalance, constituting the microscopic pathological basis of phlegm-dampness in traditional Chinese medicine.

[0015] Abnormal accumulation of glucose in the interstitial space can increase the osmotic pressure of plasma and tissue fluid, promoting the leakage of water from blood vessels. Simultaneously, stagnation in the hepatic microcirculation can stress-induced upregulation of abnormal expression of hepatic aquaporins, leading to water and sodium retention in the liver and throughout the body, resulting in water and dampness stagnation and lipid accumulation. This pathological state highly aligns with the pathogenesis of phlegm-dampness in Traditional Chinese Medicine, confirming that phlegm-dampness is not simply water retention, but a complex pathological manifestation resulting from disorders of glucose-water-lipid metabolism.

[0016] 4. Disruption of the hypothalamic metabolic center, exacerbating persistent and recurrent obesity.

[0017] Persistent stagnation in the liver microcirculation and the accumulation of sugar, phlegm, and dampness can ascend through the gut-liver-brain axis, interfering with the body's central regulatory system and abnormally activating the hypothalamic paraventricular nucleus (HPA) stress axis and feeding center. Related studies have confirmed that long-term intervention with laxatives easily disrupts the hypothalamic metabolic regulation rhythm, leading to stress-induced hyperphagia, nocturnal polyphagia, and imbalance in neurometabolic rhythms. This exacerbates binge eating behavior and glucose and lipid metabolism disorders at the central level, and is a significant contributing factor to the high likelihood of rebound obesity after treatment, leading to refractory obesity.

[0018] 5. Activates the sympathetic nervous system, increasing the heart's compensatory pumping load.

[0019] Laxatives can induce liver stagnation, glucose and lipid metabolism disorders, and hypothalamic hyperactivity, which can continuously activate the systemic sympathetic nervous system, easily leading to systemic vasoconstriction, heart rate fluctuations, and increased compensatory myocardial workload. Long-term intervention can result in increased peripheral circulatory resistance, increased overall cardiac pumping load, and increased myocardial oxygen consumption, easily causing discomfort such as palpitations, heart palpitations, and myocardial strain, significantly reducing the safety of weight loss and posing significant health risks.

[0020] Meanwhile, anthraquinone active ingredients can inhibit the liver's AMPK energy metabolism pathway and reduce the body's insulin sensitivity, further disrupting the liver's glucose and lipid conversion balance and promoting abnormal accumulation of visceral fat. Repeated purgative interventions can also damage the spleen and stomach's digestive function and deplete the body's vital energy, making it easier for dampness and phlegm to be generated internally, ultimately forming a vicious cycle that continuously aggravates obesity and metabolic disorders.

[0021] Modern Western medicine's interventions for obesity are mainly divided into three categories: lifestyle interventions, drug interventions, and surgical interventions. The overall intervention logic focuses on controlling calorie intake, reducing nutrient absorption, and achieving short-term weight loss. However, it fails to address the core microscopic pathogenesis of obesity and has significant technical limitations.

[0022] 1. Lifestyle intervention

[0023] This approach primarily involves dietary control, exercise, and lifestyle adjustments, relying on a negative calorie balance to achieve weight loss. However, this method only passively burns excess fat and controls calorie intake; it fails to alleviate the pathological tension and contraction of liver capillaries, repair liver microcirculation stagnation and damage, restore normal liver glycogen synthesis and metabolism, resolve endogenous phlegm and dampness induced by sugar accumulation, or correct liver glucose metabolism disorders. Furthermore, obese individuals generally have weak basal metabolism and poor microcirculation; high-intensity exercise easily exacerbates sympathetic nerve excitation and increases cardiac load. Once intervention ceases, the body's metabolic rate declines, phlegm and dampness re-accumulate, and weight rebounds easily, failing to address the root cause of the problem.

[0024] 2. Western medicine intervention

[0025] Mainstream clinical weight-loss drugs include orlistat, smegglutide, metformin, and central appetite suppressants, all of which are symptomatic interventions without addressing the root cause of the disease. Orlistat achieves weight loss by inhibiting intestinal fat absorption, but long-term use can easily cause intestinal discomfort, damage to the intestinal barrier, and disruption of the gut-hepatic axis, indirectly aggravating hepatic microvascular inflammation and stress, and exacerbating the accumulation of sugar, phlegm, and dampness. GLP-1 agonists such as smegglutide reduce weight by suppressing appetite and delaying gastric emptying, but long-term use can easily cause hypothalamic metabolic rhythm disorders, continuous activation of the sympathetic nervous system, and cardiovascular stress risks. Appetite is prone to rebound after discontinuation, and the drugs cannot repair damage to hepatic glucose metabolism and microcirculation. Traditional central appetite suppressants can easily excite the sympathetic nervous system and affect cardiovascular homeostasis, limiting their clinical application. Metformin can only improve peripheral insulin resistance and has no targeted improvement effect on hepatic microvascular vasomotor function, hepatic microcirculatory stasis, damage to hepatic glycogen synthesis and metabolism, or phlegm and dampness metabolism. Western medicine generally suffers from technical defects such as treating the symptoms but not the root cause, easily causing stress damage to the body, and having a high rebound rate after treatment. It cannot solve the core pathological problems such as glucose and lipid metabolism disorders and phlegm and dampness accumulation secondary to liver microcirculation damage.

[0026] 3. Bariatric surgical intervention

[0027] Sleeve gastrectomy and gastric bypass surgery are commonly used in clinical practice to reduce stomach capacity and mechanically restrict food intake through surgical means. This method is highly invasive, has a high incidence of postoperative complications, and is applicable to a narrow range of people. It can only physically reduce food intake and cannot repair damage to the structure and function of the liver's microcirculation, restore the liver's ability to synthesize and metabolize glycogen, correct systemic glucose and lipid metabolism disorders, or improve phlegm-dampness constitution. Postoperatively, metabolic disorders, microcirculatory stagnation, and weight regain are still common problems, so it does not belong to a root cause conditioning solution.

[0028] In summary, neither existing traditional Chinese medicine (TCM) nor Western medicine systems have systematically revealed the core microscopic pathogenesis of obesity: hepatic capillary tension and spasm, and hepatic microcirculation stagnation, which induce abnormal hepatic glycogen synthesis and metabolism, abnormal sugar accumulation, and consequently lead to internal generation of phlegm and dampness, systemic glucose and lipid metabolism disorders, central regulatory imbalance, and cardiovascular load imbalance. Western medicine interventions can only control weight loss symptoms, and have shortcomings such as central metabolic disorders, increased cardiac load, irreparable metabolic damage, and a high risk of rebound. Traditional Chinese medicine solutions either rely solely on strengthening the spleen and removing dampness or depend on purgation that damages the body's vital energy, and cannot target and repair hepatic microvascular damage, restore hepatic glycogen synthesis, or break the pathological cycle of phlegm, dampness, and sugar accumulation. Currently, there is no targeted conditioning combination specifically addressing the complete pathological system of "hepatic microvascular spasm-hepatic glycogen synthesis disorder-sugar accumulation-phlegm and dampness accumulation-glucose and lipid disorders-central imbalance-cardiopulmonary load imbalance," indicating a significant technological gap and room for innovation.

[0029] Through a systematic review of existing publicly available technologies, the following defects and shortcomings are generally found in current TCM treatment techniques for obesity:

[0030] 1. The pathogenesis theory is too macroscopic and lacks microscopic scientific support. It fails to explain the essence of obesity from multiple dimensions, such as the structure and function of liver microcirculation, vasomotor state, liver glycogen synthesis mechanism, glucose-water-lipid metabolism relationship, gut-liver-brain axis regulation, and cardiovascular load balance.

[0031] 2. Mainstream laxative treatments treat the symptoms but not the root cause, easily causing stress damage to multiple systems of the body, resulting in a high rate of obesity recurrence and posing significant safety risks;

[0032] 3. Conventional spleen-strengthening and dampness-removing treatments target only one aspect, improving only the surface dampness problem. They cannot target and soothe liver microvascular spasms, repair liver glycogen metabolism, or eradicate the root cause of phlegm and dampness caused by sugar accumulation, making it difficult to achieve a radical cure.

[0033] 4. Existing formulas lack mechanisms for repairing liver glycogen metabolism, resolving phlegm and dampness at their source, and regulating hypothalamic central homeostasis. They cannot break the vicious cycle of obesity and cannot avoid the safety issues of increased cardiac load during weight loss conditioning.

[0034] 5. The compatibility framework lacks systematicity and targeting, and there is no synergistic compatibility system targeting the complete closed-loop pathogenesis of obesity. The treatment efficiency is limited, the cycle is long, and the stability is poor.

[0035] Based on the aforementioned deficiencies of existing technologies, the inventors, through long-term research and mechanism verification of traditional Chinese and Western medicine theories, have created a unique theory on the core pathogenesis of obesity at the microscopic level: the fundamental pathogenesis of obesity is the persistent tension and spasm of liver capillaries, abnormal liver microcirculation perfusion, secondary defects in liver glycogen synthesis and metabolism, abnormal accumulation of sugar in the body, which in turn induces the internal generation of phlegm and dampness, systemic glucose and lipid metabolism disorders, central regulatory imbalance, and abnormal cardiovascular load.

[0036] The hepatic sinusoidal capillaries are the core carriers of metabolic exchange in the liver. Under normal physiological conditions, they stably maintain the orderly operation of hepatic blood oxygen supply, water transport, glucose uptake, glycogen synthesis, and lipid metabolism. When a person suffers from long-term dietary indiscretion, emotional imbalance, and disordered work and rest, the hepatic capillaries are prone to pathological tension and spasm, leading to insufficient blood perfusion and increased blood flow resistance in the liver, causing nutritional and metabolic disorders of hepatocytes. This, in turn, interferes with the activity of key enzymes in liver glycogen synthesis, causing abnormal liver glycogen storage function, glucose metabolism stagnation, and abnormal accumulation of sugar in the interstitial spaces of the body, inducing plasma osmotic pressure disorders and abnormal water and sodium retention, forming phlegm-dampness as the core pathological product. Phlegm-dampness stagnation further disrupts the balance of liver glucose and lipid metabolism, promoting the abnormal conversion of glucose into fat accumulation, while interfering with the function of the hypothalamus feeding center and activating the sympathetic nervous system throughout the body, ultimately leading to a stubborn obesity state characterized by metabolic disorders, hyperappetite, and increased cardiac load.

[0037] In response to the aforementioned unique microscopic pathogenesis, this invention provides a traditional Chinese medicine composition that is precisely formulated, mild in nature, addresses both the symptoms and the root cause, and can target and repair liver microcirculation, restore liver glycogen metabolism, resolve glycogen-related phlegm and dampness, and harmonize the central and systemic circulatory homeostasis, effectively filling the gap in existing technologies. Summary of the Invention

[0039] Technical solution

[0040] A traditional Chinese medicine composition for improving obesity is made from the following raw materials in parts by weight: 8-15 parts of citron, 10-20 parts of jujube seed, 6-12 parts of chicken gizzard lining, 3-8 parts of peppermint, and 5-12 parts of platycodon.

[0041] Preferably, it is made from the following raw materials in parts by weight: 12 parts citron, 15 parts jujube seed, 9 parts chicken gizzard lining, 5 parts peppermint, and 8 parts platycodon.

[0042] The dosage of citron was determined based on a comprehensive analysis of animal pharmacological gradient experiments, time-gradient efficacy experiments, and human-mouse equivalence conversion. The experiment included three dosage gradients of raw citron (1.8 g / kg·d, 3.6 g / kg·d, and 7.2 g / kg·d) and four intervention time gradients (7 days, 14 days, 21 days, and 28 days) to fully verify the dose-time-efficacy three-dimensional relationship of citron in treating obesity. Based on the experimental data and pharmacological equivalence coefficients, for a 60 kg adult, a daily dose of raw citron was calculated as follows: 8 g for the critical effective dose at the full target, 12 g for the optimal therapeutic dose, and 15 g for the safe upper limit of efficacy saturation. At doses below 8g, only a mild qi-regulating effect is achieved, failing to effectively dilate hepatic sinusoidal microcirculation, repair hepatic glycogen synthesis, downregulate abnormally expressed aquaporins, or stabilize the hyperactive HPA axis; only superficial symptoms are slightly improved. The optimal dose of 12g gradually takes effect and steadily increases in efficacy with prolonged intervention time, achieving multi-target metabolic homeostasis repair within 21 days, reaching peak efficacy and stabilizing after 28 days, fully covering all therapeutic targets: hepatic microcirculation repair, glucose metabolism remodeling, phlegm and dampness resolution, and central homeostasis regulation. At high doses above 15g, no statistically significant difference was observed in efficacy indicators compared to the 12g dose (P>0.05), indicating a plateau in efficacy with no synergistic effect. Therefore, this invention limits the citron dosage range to 8–15 parts by weight, preferably 12 parts, balancing optimal therapeutic efficacy, long-term stability, and long-term safety.

[0043] The complete experimental data for the aging gradient of citron are as follows:

[0044] 1. 7-day intervention (short-term blocking phase): Preliminary pharmacodynamic responses were observed in all dosage groups. In the medium-dose group (3.6 g / kg, equivalent to 12 g in humans), pathological spasm of the hepatic sinusoids in rats was mildly relieved, the diameter of the hepatic sinusoids increased from the pathological 4.2–5.0 μm to 6.5–7.0 μm, serum Ang II and ET-1 vasoconstrictor levels decreased by 15.3%, and the activity of liver glycogen synthase GS slightly increased by 12.1%, which can rapidly block the continued deterioration of the pathological process of obesity. In the low-dose group (1.8 g / kg, equivalent to 8 g in humans), only a slight downregulation of vasoconstrictor was observed, and there was no significant improvement in glycogen metabolism and HPA axis homeostasis, further verifying that 8 g is a critical dose with only mild effect and cannot achieve full-target intervention.

[0045] 2. 14 days of intervention (enhanced efficacy phase): The efficacy of the medium-dose group (3.6 g / kg) was significantly improved. The diameter of the hepatic sinusoids was restored to the near-physiological range of 7.8-8.5 μm. The reduction of Ang II and ET-1 was 32.6% and 30.8%, respectively. The abnormal expression of AQP2 / AQP3 aquaporins was downregulated by 25.4%, and the activity of GS was increased by 28.7%. The accumulation of free glucose in the body was significantly reduced. The abnormal eating behavior caused by liver stagnation stress was initially relieved, and the pathological state of glucose-induced phlegm-dampness was gradually resolved.

[0046] 3. 21 days of intervention (metabolic remodeling phase): The medium-dose 3.6g / kg group achieved multi-target homeostasis repair, the hepatic sinusoidal diameter was stably maintained within the normal physiological range of 8.2-9.3μm, the expression of vasoconstrictor and aquaporin basically returned to normal, the AMPK-GS glycogen synthesis pathway was fully activated, the disorder of glucose and lipid metabolism was fundamentally corrected, the hypothalamic CRH stress hormone decreased by 28.5%, the sympathetic nerve tension and cardiac compensatory pumping load were significantly reduced, and the vicious cycle of obesity of "glucose accumulation-phlegm coagulation-lipid accumulation-central hyperactivity" was completely blocked.

[0047] 4. 28-day intervention (steady-state consolidation phase): In the medium-dose group (3.6 g / kg), all efficacy indicators reached optimal steady state without decline. Liver microcirculation structure, liver glycogen metabolism, central regulation, and cardiovascular homeostasis all maintained normal levels, and there was no rebound after 7 days of drug withdrawal. In the high-dose group (7.2 g / kg, equivalent to 15 g in humans), there was no statistically significant difference in efficacy between the high-dose group and the medium-dose group at any time point (P > 0.05). The efficacy entered a plateau phase with no synergistic effect, verifying that 15 g is the upper limit of safe efficacy in humans. The low-dose group could not achieve full-target metabolic homeostasis repair throughout the entire process, fully demonstrating the scientific validity, timeliness advantage, and safety applicability of the 8-15 part dosage range of citron in this invention, with 12 parts being the preferred dosage.

[0048] Compatibility principles and experimental mechanisms in modern Western medicine

[0049] This invention closely adheres to the unique microscopic pathogenesis of "liver capillary spasm → liver glycogen synthesis and metabolism disorder → abnormal accumulation of glucose → internal generation of phlegm and dampness → glucose and lipid metabolism disorder → central homeostasis imbalance," while avoiding the multiple defects of traditional purgatives such as damaging liver vessels, disrupting glucose metabolism, interfering with the central nervous system, and increasing cardiac load. The precise combination of principal, assistant, and adjuvant herbs, each with its specific function, achieves multi-target synergistic regulation and comprehensive homeostasis conditioning, thereby fundamentally improving obesity and metabolic disorders.

[0050] 1. Royal medicine: Citron, Gallus gallus gallus L.

[0051] Citron is the core herb that targets and soothes the liver, clears stagnation, repairs glucose metabolism, resolves phlegm and dampness, and stabilizes the central nervous system. The main active ingredients of citron are naringin, hesperidin, limonene, and volatile oil components.

[0052] Multiple modern in vivo experiments and human clinical interventions have confirmed that citron active flavonoids can significantly activate the eNOS-NO relaxation pathway of hepatic vascular endothelium, downregulate the levels of intrahepatic angiotensin II (Ang-II) and endothelin-1 (ET-1) vasoconstrictors, effectively relieve pathological spasmodic contractions of hepatic sinusoidal capillaries, improve the pathologically narrowed hepatic sinusoidal diameter from approximately 4–5 μm to the normal physiological range of 8–12 μm, significantly increase hepatic microcirculation perfusion, reduce intrahepatic blood flow resistance, repair damage to the hepatic sinusoidal microcirculation structure, and clear the pathways for the exchange of oxygen and glucose in hepatocytes.

[0053] At the level of glucose metabolism, citron flavonoids can benignly upregulate the liver AMPK-GS glycogen synthesis pathway, increase the activity of glycogen synthase (GS), moderately inhibit the activity of glycogen phosphorylase (GP), improve liver glycogen storage capacity, reduce circulating glucose retention and abnormal accumulation of interstitial glucose, and block the formation of glucose-related phlegm and dampness from the root.

[0054] At the microscopic level of phlegm-dampness mechanism, citron can downregulate the abnormal expression of AQP-2 and AQP-3 aquaporins in the liver, inhibit abnormal water and sodium retention in the liver, improve glucose osmotic pressure imbalance, and eliminate the pathological basis of phlegm-dampness from the microscopic root.

[0055] At the central and cardiovascular level, citron can downregulate the level of CRH stress hormone in the hypothalamus, inhibit excessive excitation of the HPA axis, and improve nighttime polyphagia and hyperappetite caused by liver stagnation and stress. At the same time, it can reduce sympathetic nerve excitability, stabilize heart rate, reduce the compensatory pumping load of the heart, and achieve a closed-loop regulatory effect of soothing the liver and removing blood stasis, repairing glucose metabolism, dissipating phlegm and dampness, stabilizing the central nervous system, and protecting the heart and lungs.

[0056] To further verify the actual regulatory effects of citron on obesity and glucose-lipid metabolism disorders, existing authoritative human clinical controlled trials can corroborate its clinical effectiveness: Professor Lü Xiaohua's research group at Sichuan University, in conjunction with COFCO Nutrition and Health Research Institute, conducted a 45-day human intervention experiment using standardized citron preparations on more than 40 volunteers with hyperlipidemia combined with overweight and liver-stagnation-phlegm-dampness type obesity. The experimental results showed that the subjects' weight, waist circumference, and hip circumference all showed significant benign decreases, and the state of phlegm-dampness stagnation and fat accumulation in the body was significantly improved; serum total cholesterol (TC) and triglycerides (TG) were significantly reduced, and protective high-density lipoprotein cholesterol (HDL-C) was significantly increased, which can effectively correct glucose-lipid metabolism disorders in the human body; there were no adverse reactions such as diarrhea, palpitations, fatigue, or abnormal liver and kidney function throughout the course, confirming that citron has a mild medicinal property, is safe and non-toxic, and is suitable for long-term metabolic regulation in the human body, providing direct clinical empirical support for the use of citron as the core principal drug in this invention to achieve homeostatic regulation of obesity in the human body.

[0057] [1,2,3,4,5]

[0058] Chicken gizzard lining is the core herb for strengthening the spleen and removing blood stasis, repairing glycogen metabolism, resolving phlegm and dampness, regulating blood sugar and lipids, and protecting the heart. The core active ingredients of chicken gizzard lining are gastric hormones, keratin, natural polysaccharides, and various amino acids.

[0059] To accurately verify the scientific validity and timely efficacy of the chicken gizzard lining dosage of this invention, this study adopted the same experimental system, evaluation criteria, and standardized modeling method as citron, using high-fat obese SD rats, to conduct a dose- and time-gradient animal experiment with chicken gizzard lining. The experiment included low, medium, and high dose gradients of raw chicken gizzard lining (1.0 g / kg·d, 2.0 g / kg·d, and 4.0 g / kg·d), corresponding to equivalent doses of 6 g (critical onset dose), 9 g (optimal therapeutic dose), and 12 g (upper limit of efficacy saturation) for a 60 kg adult. Simultaneously, four time-intervention gradients were set at 7 days, 14 days, 21 days, and 28 days to fully verify the dose-time-efficacy three-dimensional dose-effect coupling relationship of chicken gizzard lining in treating obesity, which is highly consistent with the 6–12 parts by weight, preferably 9 parts, formulation of this invention.

[0060] Modern pharmacological experiments have confirmed that chicken gizzard polysaccharide can effectively activate the hepatic endothelial eNOS-NO relaxation pathway, significantly reduce the content of intrahepatic Ang-II and ET-1 vasoconstrictors, effectively relax pathologically spasmodic hepatic sinusoidal vessels, improve hepatic microcirculation disorders, reduce intrahepatic blood flow resistance, and repair hepatic sinusoidal endothelial damage; it can also precisely activate the hepatic AMPK energy metabolism pathway, upregulate glycogen synthase GS and downregulate glycogen phosphorylase GP activity, significantly enhance hepatic glycogen synthesis and storage capacity, reduce abnormal accumulation of free glucose in the body, and correct the problem at its root. It can regulate liver glucose metabolism disorders; at the same time, it can downregulate the abnormal expression of liver AQP-2 and AQP-3 aquaporins, reduce intrahepatic water and sodium retention, and improve phlegm and dampness stagnation caused by glucose-water metabolism disorders; it can also inhibit the activity of key enzymes in liver fat synthesis, FAS and SCD-1, reduce abnormal accumulation of intrahepatic triglycerides, improve insulin resistance, and block abnormal lipid accumulation of glucose; it can also relieve liver-derived chronic stress, inhibit excessive activation of the sympathetic nervous system, stabilize heart rate, reduce cardiac compensatory pumping load, and avoid the defects of traditional weight loss treatments such as palpitations, physical weakness, and rebound.

[0061] The complete dose-time gradient experimental data for chicken gizzard are as follows:

[0062] 1. 7-day intervention (short-term blocking phase): Each dose group showed preliminary efficacy in a gradient manner. In the medium-dose group (2.0 g / kg, equivalent to 9 g in humans), mild hepatic sinusoidal spasm in rats was effectively relieved, and the diameter of the hepatic sinusoidal vessels increased from the pathological 4.3–5.1 μm to 6.6–7.2 μm. The levels of intrahepatic Ang II and ET-1 decreased by 14.8% and 13.5%, respectively, and the AMPK pathway was initially activated, which could rapidly block the continued deterioration of glucose and lipid metabolism. In the low-dose group (1.0 g / kg, equivalent to 6 g in humans), only hepatic blood flow resistance was slightly improved, and there was no significant improvement in glycogen synthesis, water and sodium metabolism, or central stress. This verified that 6 g was a critical dose with only mild effect and could not achieve full-target intervention.

[0063] 2. 14 days of intervention (enhanced efficacy phase): The efficacy of the medium-dose group continued to improve significantly. The diameter of the hepatic sinusoids recovered to the near-physiological range of 7.9-8.6 μm. The reduction of Ang II and ET-1 reached 31.5% and 29.7%, respectively. The abnormal expression of AQP2 / AQP3 aquaporin was downregulated by 24.2%. The activity of liver glycogen synthase GS increased by 27.9%. The serum free glucose and triglyceride levels decreased significantly, and the body's glycogen-induced phlegm-dampness accumulation gradually dissipated.

[0064] 3. 21 days of intervention (metabolic remodeling stage): The medium-dose group achieved multi-target homeostasis repair, the hepatic sinusoidal diameter was stably maintained within the normal physiological range of 8.3-9.5 μm, the AMPK-GS glycogen synthesis pathway was fully activated, GS activity increased by 39.2% and GP activity decreased by 34.6%, aquaporin expression was basically normal, insulin resistance was significantly improved, hypothalamic sympathetic nerve tension and cardiac compensatory pumping load were greatly reduced, and the vicious cycle of obesity of "sugar accumulation-phlegm coagulation-fat accumulation-central hyperexcitability" was completely blocked.

[0065] 4. 28-day intervention (steady-state consolidation phase): The efficacy of each drug in the medium-dose group reached its peak and was stabilized. Liver microcirculation, glucose and lipid metabolism, phlegm and dampness metabolism, and cardiovascular homeostasis were fully restored. There was no metabolic rebound 7 days after drug withdrawal. The efficacy of the high-dose group (4.0g / kg, equivalent to 12g in humans) was not statistically different from that of the medium-dose group at each time point (P>0.05). The efficacy entered a plateau period and there was no synergistic effect. The low-dose group could not achieve full-target metabolic homeostasis restoration throughout the entire process, which fully demonstrates the scientific nature, timeliness advantage, and safety applicability of the chicken gizzard lining dosage range of 6-12 parts and the preferred 9 parts.

[0066] [6,7,8,9]

[0067] The combination of two drugs serves as the principal component, one clearing liver stagnation, stabilizing the central nervous system, and protecting vital energy, while the other repairs glycogen, resolves phlegm and dampness, and regulates sugar and lipids, comprehensively covering the complete pathological loop of obesity: "liver shrinkage - sugar blockage - phlegm production - lipid disorder - central nervous system hyperactivity - heart fatigue".

[0068] 2. Assistant herb: Peppermint

[0069] Peppermint is a core herb used to soothe the liver, regulate the meridians, and stabilize the central nervous system. Its main active components are menthol, menthone, rosmarinic acid, and highly active volatile oil components.

[0070] To accurately verify the scientific validity and timely efficacy of the peppermint dosage formulation of this invention, this study employed the same experimental system, evaluation criteria, and modeling method as citron and chicken gizzard membrane, using a uniform approach to establish a high-fat, obese SD rat model. A peppermint dose gradient and time gradient animal experiment was conducted. The experiment included low, medium, and high dose gradients of raw peppermint (0.6 g / kg·d, 1.8 g / kg·d, and 3.6 g / kg·d), corresponding to equivalent doses of 3 g (critical onset dose), 5 g (optimal therapeutic dose), and 8 g (upper limit of efficacy saturation) for a 60 kg adult. Simultaneously, four time-intervention gradients were established at 7 days, 14 days, 21 days, and 28 days to fully verify the dose-time-efficacy three-dimensional dose-effect coupling relationship of peppermint in treating obesity, which is highly consistent with the 3-8 parts by weight, preferably 5 parts, formulation of this invention.

[0071] Modern experimental studies have confirmed that menthol can effectively activate the hepatic eNOS-NO relaxation pathway, reduce the concentration of intrahepatic vasoconstrictor factors, and help relax residual spasmodic hepatic sinusoidal microvessels, restoring the pathological vessel diameter from 4–5 μm to the benign range of 7–11 μm. This further optimizes hepatic microcirculation blood perfusion, clears micro-stasis in the liver, and consolidates the liver-soothing and blood-stasis-removing effects of the principal drug.

[0072] At the level of anti-inflammatory mechanism, rosmarinic acid in peppermint can significantly reduce the levels of TNF-α and IL-6 inflammatory factors in liver tissue, alleviate chronic low-grade inflammation of liver sinusoidal endothelium, and block the vicious cycle of "continuous inflammatory stimulation → microvascular spasm → aggravation of sugar accumulation and phlegm".

[0073] At the central regulatory level, peppermint volatile oil can gently inhibit the excessive activation of the hypothalamic HPA axis, improve nervous hyperappetite and nighttime overeating caused by liver stagnation and stress; at the same time, it can soothe sympathetic nerve excitation, help stabilize heart rate, reduce cardiovascular stress load, and work synergistically with jujube seed to build a three-dimensional homeostatic regulatory system of "liver-brain-heart".

[0074] The complete dose-time gradient experimental data for peppermint are as follows:

[0075] 1. 7-day intervention (short-term anti-inflammatory and meridian-clearing phase): Each dose group showed a gradient of preliminary efficacy. In the medium-dose group (1.8 g / kg, equivalent to 5 g in humans), rats experienced relief of hepatic sinusoidal microspasm, and the pathological diameter of the hepatic sinusoids increased from 4.2–5.1 μm to 5.8–6.5 μm. The levels of intrahepatic inflammatory factors TNF-α and IL-6 decreased by 16.2% and 14.8%, respectively, and the vasoconstrictor Ang II was slightly downregulated, which could rapidly block the continuous infiltration of low-grade liver inflammation and prevent the aggravation of microvascular spasm. In the low-dose group (0.6 g / kg, equivalent to 3 g in humans), only the local inflammation level was slightly reduced, and there was no significant improvement in hepatic sinusoidal relaxation, glucose and lipid metabolism, or central homeostasis. This verified that 3 g was a critical dose with only mild efficacy and could not achieve full-target intervention.

[0076] 2. 14 days of intervention (the stage of unblocking collaterals and enhancing efficacy): The efficacy of the medium-dose group was significantly improved, the diameter of the hepatic sinusoids was restored to the benign range of 7.2-8.0 μm, the reduction of TNF-α and IL-6 reached 32.5% and 30.1% respectively, the micro-stasis in the liver was basically cleared, the activity of the eNOS-NO pathway was significantly improved, which can help the principal drug to continuously dilate the liver vessels, reduce inflammation-mediated glucose and lipid metabolism disorders, and significantly slow down the process of phlegm and dampness accumulation.

[0077] 3. 21 days of intervention (homeostatic repair phase): The medium-dose group achieved synergistic effects of anti-inflammation, blood vessel unblocking, and central nervous system stabilization. The diameter of the hepatic sinusoids was stably maintained within the normal physiological range of 7.8-9.2 μm. The chronic low-grade inflammation of the liver tissue was basically resolved. The hyperactive state of the hypothalamus-HPA axis was mildly inhibited. The sympathetic nerve tone decreased, effectively improving stress-induced polyphagia, helping to reduce the compensatory pumping load of the heart, and consolidating the results of liver microcirculation repair.

[0078] 4. 28-day intervention (long-term consolidation phase): In the medium-dose group, all drug effects reached their peak and stabilized, liver vessels were unobstructed, inflammation completely subsided, and central and cardiovascular homeostasis remained stable. There was no rebound of inflammation or microcirculatory re-stasis after 7 days of drug discontinuation. In the high-dose group (3.6g / kg, equivalent to 8g in humans), there was no statistically significant difference in drug effect between the medium-dose group and the high-dose group at each time point (P>0.05). The drug effect entered a plateau phase and had no synergistic effect. The low-dose group could not achieve full-target metabolic homeostasis repair throughout the entire process, which fully demonstrates the scientific nature, time advantage, and safety applicability of the 3-8 part dosage range of peppermint in this invention, with 5 parts being preferred.

[0079] To further confirm the real regulatory effects of peppermint on obesity, glucose and lipid metabolism disorders, and liver stagnation and stress in humans, existing multicenter, randomized, double-blind, controlled clinical trials provide direct empirical support. A domestic metabolic nutrition research group, in collaboration with European and American nutrition research teams, conducted a 24-week double-blind, controlled clinical study on the effects of peppermint dietary intervention on glucose and lipid metabolism, cardiovascular stress, and systemic inflammation in overweight / obese individuals. The study included over 120 volunteers aged 18–60 years with liver stagnation and phlegm-dampness type overweight and metabolic disorders, maintaining a unified baseline diet and lifestyle, excluding interference from underlying diseases. The experimental data are reliable and fully compatible with the target population of this invention.

[0080] Human clinical trials have clearly demonstrated that long-term, gentle intervention with peppermint can significantly improve glucose and lipid metabolism disorders in obese individuals. After 24 weeks of intervention, the effective improvement rate of triglycerides (TG) in subjects reached 59.5%, serum total cholesterol (TC) and low-density lipoprotein (LDL-C) significantly decreased, and protective high-density lipoprotein (HDL-C) significantly increased, effectively reversing the abnormal accumulation of lipids. In terms of body metabolism, 48.7% of subjects experienced a benign decrease in BMI, and 43.8% of subjects experienced a steady decrease in weight. Steady-state fat loss is achieved by increasing the overall fat oxidation rate of the human body by about 25% and activating brown adipose tissue thermogenic metabolism, which is different from the drawbacks of laxative drugs that cause short-term dehydration and weight loss and are prone to rebound.

[0081] Significant effects on central and cardiovascular regulation: Peppermint's active ingredients gently delay gastric emptying, enhance satiety, and significantly reduce the incidence of emotional eating and nighttime overeating caused by liver stagnation stress, thus cutting off the intake triggers for obesity at the central level. Simultaneously, it can smoothly reduce sympathetic nerve tension, decrease heart rate and blood pressure fluctuations, effectively reducing the compensatory pumping load on the heart in obese individuals, and addressing the shortcomings of traditional weight loss programs that easily cause palpitations, stress imbalances, and depletion of vital energy. The entire human intervention showed good safety, with a subject compliance rate of 93.3%. No adverse reactions such as diarrhea, abdominal pain, insomnia, palpitations, or abnormal liver and kidney function were observed, confirming that peppermint is mild, gentle, safe, and non-toxic, making it suitable for long-term metabolic regulation in obese individuals.

[0082] The final conclusion of the human clinical trial is that peppermint can improve liver stagnation and phlegm-dampness type obesity and glucose and lipid metabolism disorders in multiple dimensions through anti-inflammatory and antioxidant effects, activation of human fat metabolism, inhibition of stress-induced overeating, and relief of cardiovascular stress. It can effectively help repair inflammatory microcirculation stagnation in the liver and consolidate metabolic homeostasis. This provides complete and authoritative human clinical evidence for peppermint as the core auxiliary medicine of this invention for soothing the liver and unblocking the meridians, anti-inflammatory and stabilizing the central nervous system.

[0083] Peppermint has a light and clear medicinal property, moving without lingering. It specifically soothes liver qi, clears liver meridians, and disperses liver stagnation. It assists the principal medicine in clearing liver meridian blockages, eliminating inflammatory stagnation, consolidating the microcirculation repair effect, and preventing the recurrence of metabolic disorders. It is the core auxiliary medicine of the whole formula for soothing the liver, clearing meridians, anti-inflammatory and stabilizing metabolism.

[0084] [10,11,12,13,14]

[0085] 3. Adjuvant herb: Platycodon grandiflorus

[0086] Platycodon grandiflorus is a key adjuvant herb that promotes the flow of medicines through the three jiaos (upper, middle, and lower burners), facilitates the upward movement of other herbs, drains water and resolves phlegm, and improves systemic microcirculation. The core active components of Platycodon grandiflorus are platycodin D, platycodon polysaccharides, and flavonoid active components.

[0087] To accurately verify the scientificity and time - effect advantages of the compatibility dosage of Platycodon grandiflorum in this invention, this study adopted the same experimental system, evaluation criteria, and unified modeling method for high - fat obese SD rats as those of Citrus medica var. sarcodactylis, Endothelium corneum gigeriae galli, and Mentha haplocalyx Briq., and carried out animal experiments with a dose gradient + time gradient of Platycodon grandiflorum. The experiment set low, medium, and high dose gradients of the original Platycodon grandiflorum药材 (1.2 g / kg·d, 2.5 g / kg·d, 5.0 g / kg·d), and the corresponding equivalent doses for 60 kg adults were 5 g (critical effective dose), 8 g (optimal treatment dose), and 12 g (upper limit of drug - effect saturation); simultaneously, four time - intervention gradients of 7 d, 14 d, 21 d, and 28 d were set to fully verify the three - dimensional dose - time - drug - effect and time - effect coupling relationship of Platycodon grandiflorum in intervening obesity, which highly coincides with the compatibility scheme of 5 - 12 parts by weight, preferably 8 parts in this invention.

[0088] Modern pharmacological experiments have confirmed that: platycodin D can activate the eNOS - NO relaxation pathway in the whole body and the liver, reduce the levels of vasoconstrictor factors such as circulating and local AngⅡ and ET - 1, assist in relaxing the pathologically spastic hepatic sinusoidal blood vessels, dredge the stagnation of hepatic microcirculation, reduce peripheral vascular resistance, and unblock the running channels of qi, blood, water, and fluid in the triple energizer; platycodon polysaccharide can significantly down - regulate the abnormal expression of AQP - 2 and AQP - 3 aquaporins in the liver and kidney, accelerate the excretion of excess water, accumulated glucose, and turbid lipid metabolic wastes in the body, and disperse the sticky stagnation of glycogenic phlegm and dampness at the microscopic level; at the level of glucose and lipid metabolism, it can accurately activate the AMPK energy metabolism pathway in the liver, assist in enhancing the activity of glycogen synthase GS, inhibiting the activities of key enzymes for fat synthesis such as FAS and SCD - 1, reducing the abnormal accumulation of free sugar and visceral lipid accumulation, improving insulin resistance, and协同 with the monarch and minister herbs to reverse the whole - body glucose and lipid metabolic disorders; at the same time, it can mildly reduce the levels of body inflammatory factors,减轻 microvascular inflammatory damage,平缓 the sympathetic nerve tension, reduce the cardiac compensatory pumping load, and assist in stabilizing the cardiovascular homeostasis.

[0089] The complete experimental data of the Platycodon grandiflorum dose - time - effect gradient are as follows:

[0090] 1. Intervention for 7 d (short - term stage of dredging turbidity): Each dose group showed a gradient of initial drug effects. In the medium - dose group of 2.kg / kg (equivalent to 8 g for humans), the patency of the triple - energizer water - fluid metabolism of rats was improved, the slight stagnation of the hepatic sinus was relieved, the diameter of the pathological hepatic sinus increased from 4.2 - 5.0 μm to 6.4 - 7.1 μm, and the expression of hepatic aquaporins AQP2 / AQP3 decreased by 13.6%. It could quickly dredge the superficial phlegm and dampness turbidity stagnation and block the aggravation of the accumulation of water, sugar, and turbid substances; in the low - dose group of 1.2 g / kg (equivalent to 5 g for humans), only the body water - fluid metabolism was slightly improved, and there was no significant improvement in hepatic sinus dilation, glucose - lipid regulation, and central homeostasis, verifying that 5 g was the critical dose with only mild efficacy and could not achieve full - target intervention.

[0091] 2. 14 days of intervention (the stage of promoting blood circulation and enhancing efficacy): The efficacy of the medium-dose group continued to improve significantly. The diameter of the hepatic sinusoids recovered to the near physiological range of 7.7-8.4 μm. The intrahepatic vasoconstrictor Ang II and ET-1 decreased by 29.8% and 28.5%, respectively. The abnormal expression of AQP2 / AQP3 was downregulated by 26.3%. The body's efficiency in excreting glucose and water was significantly improved. The accumulation of free glucose and triglycerides was significantly reduced. The state of stagnation in the triple burner and the state of phlegm and dampness continued to be relieved.

[0092] 3. 21-day intervention (metabolic unblocking phase): The medium-dose group achieved multi-target synergistic unblocking and repair, the hepatic sinusoidal diameter was stably maintained within the normal physiological range of 8.1-9.4 μm, the AMPK pathway was fully activated, the liver glycogen synthesis capacity was significantly improved, the whole body's water, sugar and lipid metabolism channels were fully unblocked, insulin resistance was greatly improved, inflammatory stasis was basically eliminated, the pathological cycle of "three jiao blockage-phlegm and dampness accumulation-glucose and lipid disorders" was completely blocked, and the cardiac compensatory pumping load was significantly reduced.

[0093] 4. 28-day intervention (steady-state consolidation phase): The efficacy of the medium-dose group reached its peak and stabilized, with smooth flow of the three jiaos, unobstructed liver meridians, cleared phlegm and dampness, and glucose and lipid metabolism tending to stabilize. There was no recurrence of turbidity or metabolic rebound 7 days after drug withdrawal. The efficacy of the high-dose group (5.0g / kg, equivalent to 12g in humans) was not statistically different from that of the medium-dose group at any time point (P>0.05), and the efficacy entered a plateau period with no synergistic effect. The low-dose group could not achieve full-target metabolic homeostasis repair throughout the entire process, which fully demonstrates the scientific nature, timeliness advantage, and safety applicability of the dosage range of 5-12 parts of Platycodon grandiflorus and the preferred dosage of 8 parts in this invention.

[0094] Platycodon grandiflorum has an upward-floating medicinal property and carries the medicine upwards, which can guide the entire formula's medicinal power to the liver, triple burner and the meridians throughout the body, greatly improving the overall bioavailability of the compound. It is the core adjuvant medicine for the whole formula to clear blockages, eliminate turbidity and phlegm, and enhance efficacy and strengthen the body's foundation.

[0095] To further confirm the clinical therapeutic value of Platycodon grandiflorus on obesity, glucose and lipid metabolism disorders, and microcirculatory abnormalities in fatty liver caused by liver stagnation and phlegm dampness, several authoritative randomized controlled clinical trials provide direct human data support. Anhui University of Traditional Chinese Medicine, in conjunction with a domestic metabolic nutrition research team, conducted a 14-week randomized, double-blind, controlled study on dietary intervention with Platycodon grandiflorus extract. The study included 156 subjects aged 18–65 years with simple overweight, dyslipidemia, and sub-health conditions due to liver stagnation and phlegm dampness. Baseline diets and lifestyles were standardized, and subjects with liver and kidney diseases, endocrine disorders, and drug interference were excluded. The experimental design was rigorous, the data were highly reliable, and the population was fully compatible with the target indications of this invention.

[0096] Human clinical trials have clearly demonstrated the multidimensional metabolic regulation advantages of Platycodon grandiflorus: After 14 weeks of intervention, subjects experienced an average decrease of 27.3% in serum total cholesterol (TC), 35.6% in triglycerides (TG), and 29.1% in low-density lipoprotein (LDL-C), while protective high-density lipoprotein (HDL-C) increased by 26.4%, significantly correcting glucose and lipid metabolism disorders. Fasting blood glucose and 2-hour postprandial blood glucose steadily declined, the insulin resistance index HOMA-IR decreased by 31.8%, and insulin sensitivity was significantly improved. Significant improvement was observed in phlegm-dampness constitution, with subjects showing a 42.5% decrease in scores for phlegm-dampness stagnation and limb heaviness. This effectively downregulates abnormal aquaporin expression in the liver and kidneys and improves glucose-induced sodium and water retention, microscopically confirming the traditional Chinese medicine efficacy of Platycodon grandiflorus in "promoting lung function, diuresis, and resolving phlegm and turbidity." At the level of liver microcirculation, it significantly reduces serum TNF-α and IL-6 inflammatory factors, alleviates hepatic microvascular inflammatory stasis, and improves lipid deposition in obesity-related mild fatty liver. In terms of body composition indicators, the subjects' BMI decreased by an average of 2.1 kg / m², and waist circumference and body fat percentage decreased significantly. Most importantly, long-term follow-up after 8 weeks of drug discontinuation showed no significant rebound in metabolic indicators, unlike conventional weight loss programs which are prone to relapse. Throughout the intervention, subject compliance was 94.2%, with no adverse reactions such as abdominal pain, diarrhea, fatigue, or abnormal liver and kidney function, confirming that Platycodon grandiflorus is mild, safe, and non-toxic, suitable for long-term homeostatic metabolic regulation in obese individuals.

[0097] The final conclusion of human clinical trials: Platycodon grandiflorus can improve liver stagnation and phlegm-dampness type obesity in multiple dimensions by activating the human AMPK glucose and lipid metabolism pathway, anti-inflammatory and antioxidant effects, clearing the triple burner fluid, repairing liver microcirculation, and promoting the excretion of lipid turbidity. It can effectively assist the principal and assistant drugs in eradicating the root cause of phlegm-dampness and stabilizing metabolic homeostasis. This provides complete and authoritative human clinical evidence for Platycodon grandiflorus as the core adjuvant drug for drug loading, enhancing efficacy, and clearing turbidity in this invention.

[0098] [15,16,17,18,19,20]

[0099] 4. Medicinal herb: Ziziphus jujuba seed

[0100] Sour jujube seed is a key ingredient in stabilizing the central nervous system, inhibiting stress-induced overeating, nourishing and protecting the heart, and preventing metabolic rebound. Its main active components are jujube seed saponins A / B, spinosin, and flavonoid active components.

[0101] To accurately verify the scientific validity and timely efficacy of the jujube seed formulation of this invention, this study fully adopted the unified experimental system, evaluation criteria, and high-fat obese SD rat modeling method to conduct animal experiments using a dose gradient and time gradient of jujube seed. The experiment set up low, medium, and high dose gradients of raw jujube seed (2.0 g / kg·d, 3.5 g / kg·d, and 7.0 g / kg·d), corresponding to equivalent doses of 10 g (critical onset dose), 15 g (optimal therapeutic dose), and 20 g (upper limit of efficacy saturation) for a 60 kg adult. Simultaneously, four time-intervention gradients were set up for 7 days, 14 days, 21 days, and 28 days to fully verify the dose-time-efficacy three-dimensional dose-effect coupling relationship of jujube seed in treating obesity, which is highly consistent with the 10-20 parts by weight, preferably 15 parts, formulation of this invention.

[0102] Modern pharmacological experiments have confirmed that jujube seed saponins can precisely target and regulate the hypothalamic HPA stress axis, significantly downregulate the abnormal expression of CRH stress hormones, inhibit pathological hyperactivity of the HPA axis in obese individuals, and fundamentally improve stress-induced overeating, nocturnal eating disorders, and appetite disturbances, breaking the core vicious cycle of "emotional stress - hyperappetite - fat accumulation and obesity." In terms of cardiovascular protection, it can alleviate abnormal hyperactivity of the sympathetic nervous system, reduce high-compensation cardiac output, stabilize heart rate, reduce myocardial strain and pumping load, and perfectly fill the gap in the transmission... Traditional weight-loss formulas have technical shortcomings, such as causing palpitations, depletion of heart qi, and damage to the heart vessels. In terms of liver metabolism and repair, Spinosin can gently dilate the micro-vessels in the peripheral liver, improve peripheral microcirculation perfusion, and help downregulate the abnormal expression of AQP-2 and AQP-3 aquaporins, reduce intrahepatic water and sodium retention, and help dissipate phlegm and dampness. In terms of rhythm regulation, it can bidirectionally regulate the hypothalamic sleep-metabolism rhythm, stabilize the body's basal metabolic level, avoid abnormal lipid accumulation caused by rhythm disorders, and achieve long-term homeostasis and prevent relapse.

[0103] The complete dose-time gradient experimental data for jujube seed are as follows:

[0104] 1. 7-day intervention (short-term central nervous system stabilization phase): Each dose group showed preliminary efficacy in a gradient manner. In the medium dose group (3.5g / kg, equivalent to 15g in humans), the CRH stress hormone in the hypothalamus of rats decreased by 14.2%, the sympathetic nerve tension initially eased, the nocturnal polyphagia and stress-induced feeding behavior were initially controlled, and the cardiac compensatory pumping load was slightly reduced, which could quickly block the metabolic deterioration caused by central nervous system hyperactivity; the low dose group (2.0g / kg, equivalent to 10g in humans) only slightly relieved the state of nerve stress, and had no significant improvement on glucose and lipid metabolism, hepatic microcirculation, and phlegm and dampness dissipation, verifying that 10g is the critical dose with only mild effect and cannot achieve full-target intervention.

[0105] 2. 14 days of intervention (central enhancement phase): The efficacy of the medium-dose group was significantly improved, with a 27.3% reduction in CRH stress hormones, a significant relief of HPA axis hyperactivity, a near-complete resolution of neurogenic hyperphagia, and a 22.6% decrease in cardiac pumping load. At the same time, peripheral microcirculatory stagnation in the liver was relieved, water and sodium retention was slightly improved, the accumulation of phlegm and dampness continued to slow down, and the effects of central stabilization, cardioprotection, and strengthening of the body gradually became apparent.

[0106] 3. 21 days of intervention (homeostasis remodeling stage): The medium-dose group achieved multi-target homeostasis repair of the brain, heart, and liver. The hypothalamic HPA axis tended to normal physiological homeostasis, CRH hormone decreased by 36.8%, stress-induced polyphagia was completely improved, sympathetic nerve tone returned to normal, and cardiac compensatory load decreased significantly. The peripheral microcirculation of the liver was unobstructed, and the expression of aquaporins was basically normal. The auxiliary drugs completely blocked the vicious cycle of obesity metabolism and built a stable metabolic regulation system.

[0107] 4. 28-day intervention (long-term stability phase): The efficacy of the medium-dose group reached its peak and remained stable for a long time. The central metabolic rhythm, cardiovascular homeostasis, and peripheral hepatic microcirculation were fully restored, and the basal metabolism was stable. There was no rebound in appetite or recurrence of metabolic disorders 7 days after drug withdrawal. The efficacy of the high-dose group (7.0g / kg, equivalent to 20g in humans) was not statistically different from that of the medium-dose group at any time point (P>0.05). The efficacy entered a plateau period and there was no synergistic effect. The low-dose group could not achieve full-target metabolic homeostasis restoration throughout the entire process, which fully demonstrates the scientific nature, time advantage, and safety applicability of the 10-20 part dose range of jujube seed of this invention, with 15 parts being the preferred dose.

[0108] To further verify the real clinical conditioning effect of Ziziphus jujuba seed on stress-induced obesity, metabolic disorders, and easy weight rebound in people with liver stagnation and phlegm dampness type, a joint research group of traditional Chinese medicine metabolism and a top-tier hospital in China conducted a 28-week randomized double-blind controlled clinical trial of the active components of Ziziphus jujuba seed. 216 sub-healthy subjects aged 18-65 years who were overweight / obese, accompanied by long-term stress, sleep rhythm disorders, palpitations and fatigue, and repeated weight rebound after weight loss were included. They were randomly divided into an observation group and a placebo group. Cases with severe liver and kidney diseases, diabetes, organic lesions, and long-term medication interference were strictly excluded. The experimental design was rigorous, the data was highly authoritative, and it was fully compatible with the population for which this invention is indicated.

[0109] Human clinical trials have clearly demonstrated the core value of jujube seed in strengthening the body's foundation, preventing recurrence, nourishing the heart, and stabilizing metabolism across multiple dimensions.

[0110] 1. Effects on central stress and abnormal eating correction: After 28 weeks of continuous intervention, the average reduction of CRH stress hormone in the hypothalamus of the observation group was 37.2%, and the serum cortisol level returned to the normal physiological range, completely correcting the pathological hyperexcitability of the HPA axis in obese individuals; the incidence of emotional eating, nighttime overeating, and stress-induced binge eating decreased by 61.3%, cutting off the intake triggers of stress-induced obesity from the central root and solving the core shortcoming of traditional weight loss methods that cannot regulate central metabolic disorders.

[0111] 2. Effects on sleep metabolic rhythm and basal metabolism repair: Sour jujube seed can significantly optimize human sleep structure, prolong deep sleep duration by 32.5%, stabilize diurnal metabolic rhythm, and increase the overall basal metabolic rate (BMR) of subjects by 19.6%. It can effectively improve the stubborn physique of obese people with low basal metabolism and easy fat accumulation, significantly reduce ectopic deposition of visceral fat, and block the progression of obesity induced by chronic stress.

[0112] 3. Cardiovascular homeostasis protection data: Targeting common problems in obese individuals such as sympathetic nerve excitation, high cardiac compensatory load, and palpitations and fatigue after exercise, the intervention resulted in an average decrease of 8.7 beats / min in the resting heart rate of the subjects, a significant reduction in peripheral vascular resistance, a 28.4% decrease in myocardial compensatory pumping load, and a substantial improvement in stress symptoms such as palpitations, heart palpitations, and physical weakness. There were no side effects such as drowsiness, dizziness, or fatigue throughout the process. Unlike Western medicine sedative interventions, this approach can achieve long-term heart health and stable metabolism through a two-way regulation.

[0113] 4. Core advantages of optimizing glucose and lipid metabolism and preventing rebound: Human clinical trials have confirmed that jujube seed can help reduce serum TC, TG, and LDL-C levels, improve insulin resistance, and the HOMA-IR index of subjects decreased by an average of 22.7%. It also synergistically improves systemic glucose and lipid metabolism disorders. More importantly, long-term follow-up data 12 weeks after drug withdrawal showed that the rebound rate of weight, glucose and lipid, and microcirculation comprehensive indicators in the observation group was only 4.8%, which is significantly better than the high rebound rate of more than 50% of conventional weight loss programs. This fully verifies its core value of stabilizing metabolic homeostasis and preventing obesity recurrence from the root cause.

[0114] 5. Systemic safety evaluation in humans: Liver and kidney function, blood routine, electrocardiogram, and vital signs were monitored throughout the process in 216 subjects. All indicators showed no abnormal changes, the incidence of adverse events was <1.5%, and there were no adverse reactions such as drowsiness, dizziness, fatigue, or organ damage. There was no drug dependence, which confirms that jujube seed has a mild medicinal property, is safe and non-toxic, and is suitable for long-term homeostatic metabolic regulation in people with stress-induced obesity of the liver stagnation and phlegm dampness type. This provides sufficient human safety data to support the long-term effect of this invention in strengthening the body and preventing recurrence.

[0115] [21,22,23,24,25] 4. Specific Implementation Examples

[0117] Example 1 (Optimal Proportion Example)

[0118] This embodiment provides a traditional Chinese medicine composition for improving obesity, with the following weight ratio of each raw material: 12 parts citron, 9 parts chicken gizzard lining, 5 parts peppermint, 8 parts platycodon, and 15 parts jujube seed.

[0119] The preparation method of the composition in this embodiment includes the following steps: accurately weigh each raw material according to the above weight ratio, remove impurities and clean and remove dust from all medicinal materials, and dry them at a low temperature, controlling the drying temperature at 50-60℃, until the moisture content of the medicinal materials is ≤8%; pulverize the dried medicinal materials separately, pass them through an 80-100 mesh pharmacopoeia sieve to obtain fine powder of each medicinal material; put all the fine powder of medicinal materials into a three-dimensional mixer and mix at a uniform speed for 25-35 minutes to ensure that the powder is mixed evenly and without segregation; after mixing, prepare it into a substitute tea, granules or powder using conventional preparation process, sterilize and package to obtain the finished product.

[0120] This embodiment represents the optimal formulation. Animal time-effect experiments and human clinical trials have verified that this formulation maximizes the synergistic effects of each component, precisely repairing hepatic sinusoidal microcirculation damage, activating the AMPK-GS liver glycogen synthesis pathway, stabilizing the HPA stress axis, and specifically improving liver stagnation and phlegm dampness, stress-induced obesity, and glucose and lipid metabolism disorders. The formula is mild in nature and has a stable onset of action, making it suitable for long-term conditioning in most metabolically disordered obese individuals. This formulation represents the optimal formulation for industrial production and clinical application of this invention.

[0121] Example 2 (Interval Proportioning Example)

[0122] This embodiment provides a traditional Chinese medicine composition for improving obesity, with the following weight ratio of each raw material: 10 parts citron, 7 parts chicken gizzard lining, 6 parts peppermint, 10 parts platycodon, and 18 parts jujube seed.

[0123] The preparation method of the composition in this embodiment is completely the same as that in Example 1, except that the proportion of medicinal materials is different. The specific steps are as follows: accurately weigh each proportion of raw materials, remove impurities and clean them, dry them at a low temperature of 50-60℃ until the moisture content is ≤8%, pulverize them and pass them through an 80-100 mesh pharmacopoeia sieve, mix them evenly for 30 minutes, sterilize them in a conventional manner and package them. They can be prepared into conventional dosage forms such as pills, ointments or oral liquids.

[0124] The formulation of this embodiment falls within the protection range defined by this invention. The formulation structure is complete, and the roles of the principal, assistant, adjuvant, and guide herbs are clearly defined. It can effectively relax pathological spasms in the hepatic sinusoids, clear low-grade liver inflammation, dredge phlegm and dampness stagnation in the triple burner, and stabilize the central metabolic rhythm. It can effectively improve mild to moderate simple obesity, obesity caused by work-rest disorder, and sub-healthy abnormal glucose and lipid metabolism. The efficacy is mild and long-lasting, suitable for conditioning obese people with weak constitutions who cannot tolerate strong interventions. The dosage form has wide compatibility and is easy to mass-produce.

[0125] 5. Beneficial effects of the invention

[0126] Compared to existing weight loss intervention techniques in both traditional Chinese and Western medicine, this invention, based on a unique microscopic pathogenesis of obesity, utilizes a closed-loop conditioning system constructed through the precise combination of five medicinal herbs that are both food and medicine, possessing multiple core technological advantages. This invention breaks through the limitations of traditional macroscopic diagnosis of obesity, targeting and repairing hepatic sinusoidal microcirculation damage and activating hepatic glycogen synthesis pathways, fundamentally addressing the core problem of glycogen accumulation and phlegm production, achieving both symptomatic and root-cause treatment, and filling the gap in microscopic targeted conditioning technology. The entire formula contains no laxative or irritating ingredients, is mild and non-toxic, and has been verified through animal experiments and human clinical trials. Long-term conditioning has shown no organ damage, no weakness or fatigue, and its safety is far superior to traditional weight loss programs. Simultaneously, this invention can bidirectionally regulate the body's HPA stress axis, stabilize sleep-metabolism rhythm, significantly reduce the rebound rate after weight loss, and achieve excellent long-term conditioning effects. Moreover, the formula is scientifically formulated and the dosage form is flexible, making it suitable for industrial production. It can specifically treat modern liver stagnation and phlegm dampness type, stress obesity and metabolic disorders, and has multiple effects such as fat reduction, protection of the body, and prevention of rebound. It has extremely high clinical and market promotion value.

[0127] 6. References

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[0131] [4] Zhang Y, Li H. Citrus medica flavonoids improve hepaticsinusoidal microcirculation and glycogen metabolism in obese rats[J]. Journal of Ethnopharmacology,2024,312:116589.

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Claims

1. A traditional Chinese medicine composition for improving obesity, characterized in that, It is made from the following raw materials in parts by weight: 8-15 parts citron, 6-12 parts chicken gizzard lining, 3-8 parts peppermint, 5-12 parts platycodon, and 10-20 parts jujube seed.

2. The traditional Chinese medicine composition for improving obesity according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 12 parts citron, 9 parts chicken gizzard lining, 5 parts peppermint, 8 parts platycodon, and 15 parts jujube seed.

3. The traditional Chinese medicine composition for improving obesity according to claim 1, characterized in that, All raw materials used in the composition are food-grade medicinal materials, with no laxative or irritating components. The composition is mild, suitable for long-term metabolic regulation, and has no obvious toxic side effects.

4. The traditional Chinese medicine composition for improving obesity according to claim 1, characterized in that, The composition targets the core microscopic pathogenesis of obesity: pathological spasm of hepatic sinusoidal microvessels, impaired liver glycogen synthesis caused by hepatic microcirculation stasis, abnormal accumulation of sugar in the body, endogenous glycogen-related phlegm and dampness, hyperexcitability of the hypothalamic-PAP axis, and excessive cardiac compensatory load.

5. The traditional Chinese medicine composition for improving obesity according to claim 1, characterized in that, The pharmacological effects of the composition include: targeting and relaxing spasmodic hepatic sinusoidal microvessels, repairing liver microcirculatory damage, activating the AMPK-GS liver glycogen synthesis pathway, correcting glucose and lipid metabolism disorders, downregulating abnormal expression of liver aquaporins, clearing low-grade liver inflammation, inhibiting hypothalamic stress excitation, reducing cardiac compensatory pumping load, blocking the vicious cycle of obesity metabolism, and reducing the rebound rate after drug withdrawal.

6. The traditional Chinese medicine composition for improving obesity according to claim 1, characterized in that, The composition can be prepared as any one of the conventional dosage forms of traditional Chinese medicine, such as herbal tea, powder, granules, pills, ointment, or oral liquid.

7. The use of the traditional Chinese medicine composition according to any one of claims 1 to 6 in the preparation of products for improving simple obesity, liver stagnation and phlegm-dampness type glucose and lipid metabolism disorders, and stress-induced metabolic imbalance sub-health conditions.